Kyushu, Japan
NCT Number: NCT01450579
A Study to Evaluate the Immune Response to the ASP7373 and Its Safety in Healthy Adult Volunteers
This trial is to investigate the clinically recommended dosage for ASP7373 based on the comparison of the immunogenicity and safety among the three doses of ASP7373 in healthy adults.
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Notify MeKey information
Conditions
Age range
20 year–40 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 2
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Body weight: Female: ≥40.0 kg, <70.0 kg, Male: ≥50.0 kg, <80.0 kg
- BMI: ≥17.6, <26.4
- Healthy, as judged by the investigator or sub-investigator based on the results of physical examinations (subjective symptoms and objective findings) and all tests obtained
Exclusion criteria
- Scheduled to receive another vaccine during study period
- History of H5 influenza infection or received H5 influenza vaccine
- Past history of anaphylactic shock or an allergic reaction such as generalized eruption due to food or drug (including vaccines) allergies, fever ≥ 39.0°C within 2 days after the previous vaccination (influenza vaccine and others)
- Diagnosis of immune deficit in the past, has a family member (within the third degree of kinship) with a diagnosis of congenital immunodeficiency syndrome
- Received or scheduled to receive a live vaccine within 28 days prior to vaccination of the study vaccine, and received or scheduled to receive an inactivated vaccine or a toxoid within 7 days prior to vaccination of the study vaccine
- History of seizures
- Female subjects who are breastfeeding, pregnant, possibly pregnant, and planning to become pregnant during the study period
Treatment and study plan
ASP7373
BiologicalIntermuscular administration
Placebo
BiologicalIntramuscular administration
Primary outcomes
-
Safety assessed by the incidence of adverse events, vital signs, laboratory tests and 12-lead ECGs
Time frame: up to 43 days
-
Immunogenicity (HI antibody titer)- first vaccine
Time frame: on Day 21
-
Immunogenicity (HI antibody titer)- second vaccine
Time frame: on Day 43
second vaccination on Day 22
Sponsors and collaborators
Lead sponsor
UMN Pharma Inc.
Industry
Registry information
Official study title
Phase II Study of ASP7373 Evaluation of Immunogenicity and Safety of ASP7373 in Healthy Adults
Important dates
- Study start
- 2011
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Oct 12, 2011
- Registry last updated
- Sep 29, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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